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Alector Reports Fourth Quarter and Full Year 2025 Financial Results and Provides Business Update
Globenewswire· 2026-02-25 21:05
Advancing the Alector Brain Carrier (ABC) platform across multiple therapeutic modalities, including antibodies, enzymes, and siRNA, with continued progress across AL137 (ABC-enabled anti-amyloid antibody for Alzheimer’s Disease), AL050 (ABC-enabled GCase Enzyme Replacement Therapy for Parkinson’s Disease) and AL064 (ABC-enabled Tau siRNA for Alzheimer’s Disease) Independent interim futility analysis of the PROGRESS-AD Phase 2 trial of nivisnebart (AL101) in early Alzheimer’s disease expected in the first h ...
Revolution Medicines Reports Fourth Quarter and Full Year 2025 Financial Results and Update on Corporate Progress
Globenewswire· 2026-02-25 21:02
On track for readout of RASolute 302, a Phase 3 trial of daraxonrasib in second line metastatic PDAC, in first half of 2026Continues to advance broad late-stage pipeline, with five ongoing Phase 3 trials and three additional Phase 3 trials planned to initiate in 2026Expects to substantially complete enrollment in RASolve 301, a Phase 3 trial of daraxonrasib in previously treated NSCLC, this yearInitiated RASolute 305, the first Phase 3 trial for zoldonrasib, in first line metastatic PDAC harboring a RAS G12 ...
Celldex Reports Fourth Quarter and Year End 2025 Financial Results and Provides Corporate Update
Globenewswire· 2026-02-25 21:01
Enrollment completed in both Phase 3 chronic spontaneous urticaria global registration studies (EMBARQ-CSU 1 and 2) six months ahead of guidance; Topline data expected in Q4 26; BLA submission planned for 2027Phase 3 cold urticaria and symptomatic dermographism study (EMBARQ-ColdU and -SD) actively accruing Enrollment completed in Phase 2 prurigo nodularis and atopic dermatitis studies with topline data expected in 2026 Phase 1 CDX-622 Proof of Mechanism study in asthma initiatedCompany prepares for landmar ...
Larimar Therapeutics Announces Proposed $75 Million Underwritten Public Offering
Globenewswire· 2026-02-25 21:01
BALA CYNWYD, Pa., Feb. 25, 2026 (GLOBE NEWSWIRE) -- Larimar Therapeutics, Inc. (“Larimar”) (Nasdaq: LRMR), a clinical-stage biotechnology company focused on developing treatments for complex rare diseases, today announced that it has commenced an underwritten public offering of $75 million of shares of its common stock and, in lieu of common stock to certain investors that so choose, pre-funded warrants to purchase shares of its common stock. In addition, Larimar expects to grant the underwriters a 30-day o ...
Celcuity To Participate in Upcoming Investor Conferences
Globenewswire· 2026-02-25 21:01
MINNEAPOLIS, Feb. 25, 2026 (GLOBE NEWSWIRE) -- Celcuity Inc. (Nasdaq: CELC), a clinical-stage biotechnology company pursuing development of targeted therapies for oncology, today announced that Brian Sullivan, Chief Executive Officer, and Co-founder of Celcuity, will present and be available for one-on-one investor meetings at the following investor conferences: A fireside chat at the TD Cowen 46th Annual Healthcare Conference at 10:30 a.m. ET on Wednesday, March 4, 2026. A live webcast will be available us ...
Structure Therapeutics Stock Soars Over 200% as One Fund Adds to a $242 Million Position
Yahoo Finance· 2026-02-25 20:55
With a focus on innovative oral therapies, Structure Therapeutics aims to address large patient populations underserved by current treatment options, positioning itself as a differentiated player in the global biopharmaceutical landscape.Structure Therapeutics is a clinical-stage biotechnology company specializing in the development of oral small molecule therapeutics for chronic diseases with significant unmet need. The company leverages expertise in G-protein-coupled receptor (GPCR) biology to advance a p ...
Pliant Therapeutics (NasdaqGS:PLRX) FY Conference Transcript
2026-02-25 20:42
Summary of Pliant Therapeutics FY Conference Call Company Overview - **Company**: Pliant Therapeutics (NasdaqGS:PLRX) - **Focus**: Transitioning from fibrosis to oncology, leveraging an integrin small molecule platform developed over the past 10 years [3][4] Key Points Transition to Oncology - Pliant has shifted its focus from fibrosis to oncology, with a pipeline based on its integrin targeting small molecule platform [3][4] - The most advanced program is **PLN-101095**, a dual v8, v1 integrin small molecule blocker aimed at treating solid tumors, particularly in patients refractory to immune checkpoint inhibitors [4][9] Clinical Data and Pipeline - Initial Phase 1 study of PLN-101095 showed encouraging safety and pharmacokinetic data, with significant biomarker changes observed [4][14] - The drug is administered orally, twice daily, and aims to reduce immune suppression in tumors by blocking TGF- activation [10][11] - A Phase 1b dose expansion study is set to begin in the second quarter of 2026, focusing on combination therapy with Pembrolizumab [15][19] Biomarker Insights - A notable increase in interferon gamma (3-12 fold) was observed in responders during the monotherapy phase, suggesting it may serve as a predictive biomarker for treatment response [14][28][29] - The average tumor size reduction in responders was 71%, with an overall response rate of 40% in secondary refractory patients [27] Future Development Plans - Plans to initiate a Phase 1b study with a focus on specific tumor types, including non-small cell lung cancer and renal cell carcinoma, based on v8 expression profiles [16][17][19] - Continuous evaluation of external opportunities for in-licensing or acquisition of complementary assets [7][36] Financial Position - As of the third quarter, Pliant reported approximately **$211 million** in cash, with a burn rate significantly decreased, providing a runway into the second half of 2028 [40][41] - The company has restructured to maintain development capabilities while reducing operational costs [42][43] Competitive Landscape - Pliant's approach is differentiated from competitors, as it utilizes a small molecule that targets both v1 and v8 integrins, unlike other antibody-based therapies in development [21][22] - The company is monitoring other TGF- targeted programs to inform its indication selection [23][24] Additional Insights - The targeted drug delivery platform using siRNA is being developed internally, with a focus on selective delivery to specific cell types [5][37] - The company aims to provide updates on clinical execution and data from non-human primate studies later in the year [35][36] This summary encapsulates the key points discussed during the conference call, highlighting Pliant Therapeutics' strategic transition, clinical developments, financial health, and competitive positioning in the oncology space.
Bicara Therapeutics Inc. (BCAX) Discusses Ficerafusp Alfa Clinical Data and Less Frequent Dosing in First-Line HPV-Negative Head and Neck Squamous Cell Carcinoma Transcript
Seeking Alpha· 2026-02-25 20:38
PresentationI would now like to turn the call over to your speaker for today, Jenna Cohen, Chief Corporate Affairs Officer of Bicara Therapeutics. Please go ahead.Good day, and thank you for standing by. Welcome to the Bicara MHNCS Clinical Call Update. [Operator Instructions] Please be advised that today's call is being recorded.Jenna CohenChief Corporate Affairs Officer Thank you, and good morning, everyone. It's a pleasure to welcome you to Bicara Therapeutics' conference call. Yesterday, coinciding with ...
Q32 Bio (NasdaqGM:QTTB) FY Conference Transcript
2026-02-25 20:02
Summary of Q32 Bio FY Conference Call Company Overview - **Company**: Q32 Bio (NasdaqGM:QTTB) - **Focus**: Development of bempikibart, a fully human antibody targeting alopecia areata and other diseases Key Points and Arguments Product Development - **Lead Asset**: Bempikibart is the primary focus, currently in development for alopecia areata, with proof of concept already established [2][3] - **Mechanism of Action**: Bempikibart binds to the IL-7 alpha receptor, blocking Th2 and Th1 cytokine signaling, which may provide broad therapeutic benefits across various diseases [2] - **Market Potential**: The alopecia areata market is expected to reach $2.6 billion by 2030, with a significant unmet need for biologics in this space [3] Clinical Trials - **SIGNAL-AA Study**: - Part A completed with positive results, leading to an open-label extension due to high patient demand [4] - Part B has enrolled 33 patients, with top-line data expected by mid-year 2026 [4][17] - The study design includes a 36-week dosing period and a focus on patient safety and response durability [9][10] Efficacy and Safety - **Part A Results**: Showed a statistically significant drop in SALT percentage, indicating meaningful hair growth responses [5][6] - **Durability of Response**: Continued hair growth observed even after treatment cessation, suggesting potential advantages over JAK inhibitors [6][7] - **Safety Profile**: Bempikibart's safety profile is favorable compared to JAKs, positioning it as a safer alternative for chronic use [8][12] Market Dynamics - **Current Treatment Landscape**: JAK inhibitors are the only approved treatments for alopecia areata, but their market penetration remains limited [25][26] - **Commercial Opportunity**: Bempikibart is expected to penetrate the market significantly and expand it, similar to trends seen with biologics in other conditions [25][26] Future Directions - **Phase III Plans**: Efficacy signals from Part B will inform the design of Phase III studies, with a target for SALT 20 responses in the mid-20s percentage range [61][62] - **Potential Indications**: While alopecia areata remains the primary focus, there are opportunities for bempikibart in other inflammatory diseases such as ulcerative colitis and celiac disease [61][62] Financials and Strategic Moves - **Partnership with Akebia**: Q32 Bio sold ADX-097 to Akebia for $12 million upfront, with potential total milestones of up to $592 million, allowing the company to focus on bempikibart [65][66] Conclusion - **Upcoming Milestones**: Anticipation for mid-year 2026 top-line results from the SIGNAL-AA study, which are expected to be significant for the company's future [68] This summary encapsulates the key points discussed during the conference call, highlighting Q32 Bio's strategic focus on bempikibart, its clinical development progress, market potential, and future directions.
Inovio Pharmaceuticals, Inc. (INO) Presents at Oppenheimer 36th Annual Healthcare Life Sciences Conference Transcript
Seeking Alpha· 2026-02-25 19:57
PresentationHello, everyone, and welcome to Oppenheimer's 36th Annual Life Science Conference. I'm Jay Olson, one the biotech analysts here at Oppenheimer, and it's a pleasure to welcome you to our discussion with Inovio Pharmaceuticals. And it's an honor to introduce Jacqui Shea, the CEO; and Mike Sumner, the CMO of Inovio. With that, I'll turn it over to you, Jacqui, for a few slides to set up our discussion before we start to fireside. And thank you so much for joining us here today.Jacqueline SheaCEO, P ...